NDC 68071-4369

Clarithromycin 500 mg

Clarithromycin

Clarithromycin 500 mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Clarithromycin.

Product ID68071-4369_68f39535-54c1-c2f9-e053-2991aa0a0d6b
NDC68071-4369
Product TypeHuman Prescription Drug
Proprietary NameClarithromycin 500 mg
Generic NameClarithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-10-12
Marketing CategoryANDA / ANDA
Application NumberANDA202710
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameCLARITHROMYCIN
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4369-4

14 TABLET, FILM COATED in 1 BOTTLE (68071-4369-4)
Marketing Start Date2018-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4369-4 [68071436904]

Clarithromycin 500 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-03

NDC 68071-4369-3 [68071436903]

Clarithromycin 500 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-03

NDC 68071-4369-2 [68071436902]

Clarithromycin 500 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-03

NDC 68071-4369-8 [68071436908]

Clarithromycin 500 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-03

Drug Details

Active Ingredients

IngredientStrength
CLARITHROMYCIN500 mg/1

OpenFDA Data

SPL SET ID:68f38815-d0f2-b99f-e053-2991aa0a00ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197517

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "Clarithromycin 500 mg" or generic name "Clarithromycin"

    NDCBrand NameGeneric Name
    68071-4369Clarithromycin 500 mgClarithromycin 500 mg
    71335-0990Clarithromycin 500 mgClarithromycin 500 mg
    50090-3193Clarithromycin 500 mgClarithromycin 500 mg
    59746-743Clarithromycin 500 mgClarithromycin 500 mg
    0054-0036Clarithromycinclarithromycin
    0054-0037Clarithromycinclarithromycin
    0093-7528ClarithromycinClarithromycin
    0093-7529ClarithromycinClarithromycin
    0527-1930ClarithromycinClarithromycin
    0527-1931ClarithromycinClarithromycin
    0527-1932ClarithromycinClarithromycin
    0591-2805clarithromycinclarithromycin
    0781-1961ClarithromycinClarithromycin
    0781-1962ClarithromycinClarithromycin
    0781-6022ClarithromycinClarithromycin
    0781-6023ClarithromycinClarithromycin
    0904-6872ClarithromycinClarithromycin
    10544-522ClarithromycinClarithromycin
    10544-952Clarithromycinclarithromycin
    21695-557ClarithromycinClarithromycin
    21695-558ClarithromycinClarithromycin
    27241-064ClarithromycinClarithromycin
    27241-065ClarithromycinClarithromycin
    33261-618ClarithromycinClarithromycin
    33261-631ClarithromycinClarithromycin
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.